Associate Director, Regulatory Systems & Capability Strategy

Takeda Pharmaceutical Co.; Boston (MA); On-site; USD 154,000 - 243,000; Full time

Job summary

Responsibilities include roadmapping, prioritizing demand, eliciting and documenting requirements, and guiding delivery with cross-functional workshops. A strong emphasis on collaboration, quality, and data integrity is essential for global regulatory programs.

Qualifications

• Bachelor’s degree required; advanced degree preferred.
• 8–12+ years in Regulatory Affairs or related domain.
• Experience with regulatory systems (RIM preferred).
• Experience supporting cross-functional initiatives and requirements-driven delivery.

Responsibilities

• Support development and refinement of regulatory capability roadmaps aligned to GRA priorities
• Partner with Business System Owners to structure and prioritize demand, backlog, and enhancements
• Elicit, document, and refine business requirements, ensuring clarity and alignment to regulatory needs
• Facilitate cross-functional workshops with SMEs and Process Owners to define use cases
• Translate business needs into structured requirements for downstream design and delivery
• Ensure consistency and reuse of requirements, capabilities, and design patterns
• Coordinate with Digital & Technology teams to support delivery of solutions
• Identify opportunities for process optimization and system improvements
• Support adoption of best practices in capability modeling and requirements management

Skills

Regulatory processes

Requirements elicitation

Stakeholder engagement

Cross-functional collaboration

Documentation

Education

Bachelor’s degree

Advanced degree preferred

Tools

RIM

Job description

Responsibilities include roadmapping, prioritizing demand, eliciting and documenting requirements, and guiding delivery with cross-functional workshops. A strong emphasis on collaboration, quality, and data integrity is essential for global regulatory programs.